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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group study to investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome (AEGIS – II Study).

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT03473223

Background Information

The most common cause of a heart attack is the build-up of excess cholesterol. Heart attacks can be life-threatening and even after recovery; patients can remain at high risk for further heart-related problems. The study drug being studied is called CSL112 and is similar to High Density Lipoprotein (HDL) aka “good cholesterol” in that it works at removing excess cholesterol from arteries. CSL112 is not yet approved by the US Food and Drug Administration (FDA) but it has been studied in previous research studies in healthy adults, in stable subjects with heart disease, and in heart attack subjects with varying degrees of kidney function. The purpose of this study is to find out how effective and safe CSL112 is at reducing the risk of heart related events such as having another heart attack, or having a stroke. Approximately 17,000 subjects will take part in this study in hospitals around the world.

Offered At

Inova Fairfax Hospital – Inova Heart & Vascular Institute
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Christopher Defilippi, MD

Eligibility Information

  • Male or female at least 18 years of age
  • Evidence of type I (spontaneous) MI
  • Stable renal function and no suspicion of acute kidney injury at least 12 hours after angiography OR after first medical contact for the index MI for subjects not undergoing angiography
    • Stable renal function for those undergoing angiography is defined as a change in serum creatinine that is <0.3 mg/dL increased from the pre-contrast value
  • Evidence of multivessel coronary artery disease defined as meeting 1 or more of the following criteria:
    • At least 50% stenosis on more than 1 epicardial artery or the left main artery on a current or past cardiac catheterization OR
    • Prior PCI and evidence of at least 50% stenosis of at least 1 epicardial artery different from prior revascularized artery OR prior multivessel coronary artery bypass grafting.
  • ≥ 1 of the following established risk factors:
    • Age > 65 years
    • Prior history of MI
    • On pharmacological treatment for diabetes mellitus
    • Peripheral arterial disease
  • Female subjects of child bearing potential must be willing to use an acceptable method of contraception during the active treatment period

Ineligibility Information

  • Ongoing hemodynamic instability
    • History of NYHA Class III or IV heart failure within the last year
    • Ongoing Killip Class III or IV heart failure
    • Sustained and/or symptomatic hypotension (SBP< 90 mm Hg)
    • Known left ventricular ejection fraction of < 30%
  • Evidence of hepatobiliary disease as indicated by any 1 or more of the following at screening:
  • Severe chronic kidney disease (eGFR of < 30mL/min/1.73m2) or on dialysis
  • Body weight less than 50 kg
  • Allergy to soy bean or peanuts
  • Other severe co-morbid condition, concurrent medication or other issue that renders the subject unsuitable